Simcor Side Effects

Note: This page contains side effects data for the generic drug niacin / simvastatin. It is possible that some of the dosage forms included below may not apply to the brand name Simcor.

It is possible that some side effects of Simcor may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to niacin / simvastatin: oral tablet extended release

As well as its needed effects, niacin / simvastatin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking niacin / simvastatin, check with your doctor immediately:

Incidence not known

Abdominal or stomach pain, severe

black, tarry stools

chills

dark-colored urine

dizziness

fever

headache

light-colored stools

loss of appetite

muscle cramps or spasms

muscle pain or stiffness

muscular tenderness, wasting, or weakness

nausea or vomiting

rash

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some niacin / simvastatin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

Less common

Back pain

diarrhea

itching skin

For Healthcare Professionals

Applies to niacin / simvastatin: oral tablet extended release

General

Niacin-simvastatin treatment was discontinued by 14% of patients in a controlled clinical trial due to an adverse event. Flushing episodes (including warmth, redness, itching, and/or tingling) were the most common side effects reported by patients using niacin-simvastatin.

Musculoskeletal

Musculoskeletal side effects have included back pain (3.2%), myopathy, and rhabdomyolysis have been associated with simvastatin therapy. The risk of myopathy/rhabdomyolysis is dose related and is increased by concomitant use of simvastatin with potent Inhibitors of CYP450 3A4, as well as cyclosporine or danazol, particularly with higher doses of simvastatin.[Ref]

Hepatic

Liver function tests should be performed before treatment begins, every 12 weeks for the first 6 months, and periodically thereafter (e.g., at approximately 6-month intervals). Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. If a persistent increase in transaminase levels is seen (e.g., three times the upper limit of normal), or if transaminase elevations are associated with symptoms of nausea, fever, and/or malaise, withdrawal of niacin-simvastatin therapy is recommended.[Ref]

Dermatologic

Dermatologic side effects including flushing (59%) and pruritus (3.2%) were reported in patients receiving the combination niacin-simvastatin product. Flushing episodes have also been associated with niacin monotherapy (in up to 88% of patients).[Ref]

Other

Other side effects including headache (4.5%) and back pain (3.2%) have been associated with the combination niacin-simvastatin product.[Ref]

Gastrointestinal

Gastrointestinal side effects associated with administration of the combination product have included nausea (3.2%) and diarrhea (3%). Diarrhea has also been associated with each of the individual components of the drug. Abdominal pain, constipation, and flatulence have also been associated with simvastatin monotherapy, while nausea and dyspepsia have been associated with niacin monotherapy.[Ref]

Respiratory

Respiratory side effects including upper respiratory infection and rhinitis have been associated with simvastatin and niacin, respectively.[Ref]

Metabolic

Metabolic side effects including increased serum glucose levels have been associated with niacin therapy. Therefore, glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use.[Ref]

Psychiatric

Psychiatric side effects reported postmarketing have included cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

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